The Food and Drug Administration issued a recall on thousands of Tydemy birth control pills brand on Tuesday after drugmaker Lupin Pharmaceuticals discovered two lots of the tablets it produced might not be as effective as others.
The FDA’s website lists two distinct lot numbers as the two Tydemy batches that have been recalled. Tydemy is a prescription contraceptive pill combination that contains both estrogen and progestin.
From June 2022 through May 2023, according to the FDA, the goods were disseminated to pharmacies and grocery stores across the country.
According to the FDA’s database, a total of 4,179 boxes have been recalled, which equates to around 350,000 tablets that might be less effective at ending pregnancy.
People who are currently using recalled quantities of the medications are advised to keep taking their pills but to immediately ask their doctor for a different prescription.
To make sure that the medicines they produce are still safe to use past their expiration dates, drugmakers regularly do what is known as stability testing.
Lupin Pharmaceuticals Recalls Birth Control Pills
According to Lupin, so far, “no reports of adverse events related to either recalled batches from the current birth control pill recall” have been received.
The FDA advises physicians or patients who have problems with the tablets to contact the organization online or by fax.
It is unknown what caused the alleged out of specification issue or whether more batches may also be impacted. Requests for comment from a Lupin Pharmaceuticals spokeswoman went unanswered.
The firm, which bills itself as the third-largest pharmaceutical company in the US by prescriptions, has issued recalls before. Lupin recalled batches of the blood pressure drug Quinapril late last year after discovering contaminants.
A facility maintained by the corporation was inspected in March, and a number of issues were discovered, including the failure to identify the underlying reasons of various test findings that were outside of tolerance.
Your companies do not fully investigate deviation investigations, and no suitable steps are done to stop a recurrence.